HBVAXPRO 5mcg
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 24 July 2024
File name
QRD-IE-UKNI-HBVAXPRO 5 mcg-en-LFT-Art 61-3-081-CRT-15072024.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Free text change information supplied by the pharmaceutical company
N/0081 - Art.61(3) to change LoLR e-mail address IE+BE+LU+SK+PL+DK+GR, editorial updates in section 6.
Updated on 18 July 2022
File name
QRD-IE-UKNI-HBVAXPRO-5MCG-PIL-II-076-20220602.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 15 July 2022
File name
HBVAXPRO-5mcg-PFS-H-C-0373-II-076-SPC-IE-en-June2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to the duration of protection in section 5.1, editorial changes such as a change from ml to mL and minor formatting updates throughout.
Updated on 25 April 2022
File name
HBVAXPRO-5mcg-PFS-H-C-0373-T-075-G-SPC-IE-en-April 2022.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Transfer - MSD VACCINS to MSD B.V.
Updated on 25 April 2022
File name
QRD-IE-HBVAXPRO-5MCG-LFT-IB074G-T-075-20220404.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 July 2021
File name
HBVAXPRO-5mcg-PFS-H-C-0373-II-071-G-SPC-IE-en April 2021.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to plunger stopper (gray chlorobutyl or bromobutyl).
Updated on 08 July 2021
File name
QRD-IE-HBVAXPRO-5MCG-LFT-II071G-29042021.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 19 March 2020
File name
QRD_IE_HBVAXPRO_5MCG_Leaflet_IB067 (002).pdf.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 10 February 2020
File name
QRD_IE_HBVAXPRO_5MCG_Leaflet_IB067 (002).pdf
Reasons for updating
- Change to section 6 - what the product contains
Updated on 10 February 2020
File name
HBVAXPRO-5mcg-PFS-H-C-0373-IB-067-SPC-IE-en Jan 2020 (002).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Added “Traceability” heading
Updated on 10 February 2020
File name
QRD_IE_HBVAXPRO_5MCG_Leaflet_IB067 (002).
Reasons for updating
- Change to section 6 - what the product contains
Updated on 11 March 2019
File name
QRD_IE_HBVAXPRO5MCG_Leaflet_II064.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 08 March 2019
File name
BM HBVAXPRO-5mcg-PFS-H-C-0373-II-064-SPC-IE-en Jan 2019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 2: Added text: “Excipient(s) with known effect: Sodium less than 1mmol (23mg) per dose.”
- Section 4.4: Added text: “Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23mg) per dose, and is considered to be essentially sodium free.”
- Section 6.4: Added text: “Store in the original package in order to protect from light. HBVAXPRO should be administered as soon as possible after being removed from refrigeration. HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours. Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours. These are not, however, recommendations for storage.”
Updated on 08 March 2019
File name
HBVAXPRO-5mcg-PFS-H-C-0373-II-064-SPC-IE-en Jan 2019.
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 2: Added text: “Excipient(s) with known effect: Sodium less than 1mmol (23mg) per dose.”
- Section 4.4: Added text: “Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23mg) per dose, and is considered to be essentially sodium free.”
- Section 6.4: Added text: “Store in the original package in order to protect from light. HBVAXPRO should be administered as soon as possible after being removed from refrigeration. HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours. Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours. These are not, however, recommendations for storage.”
Updated on 28 August 2018
File name
QRD_IE_HBVAXPRO5MCG_Leaflet_BRX_PRO (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 03 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 March 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 March 2017
File name
PIL_10984_282.pdf
Reasons for updating
- New PIL for new product
Updated on 02 March 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 January 2017
Reasons for updating
- Change to MA holder contact details
Updated on 05 June 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), how to report side effects has been added
In section 7 the marketing authorisation has been updated with the new Lyon address
In section 10, date of revision has been updated
Updated on 05 June 2014
Reasons for updating
- Change to MA holder contact details
- Addition of information on reporting a side effect.
Updated on 09 September 2013
Reasons for updating
- Change to further information section
Updated on 10 April 2013
Reasons for updating
- Change to further information section
Updated on 03 October 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In section 4.8, Uveitis has been added as an undesirable effect under a new category of Eye Disorder
- In section 4.4, 'vial stopper' has been deleted and replaced with 'the syringe plunger stopper and tip cap' in the latex warning paragraph
- In section 9, the date of the last renewal has been updated to 27/4/2011
- In section 10, the date of revision text is now 08/2011
Updated on 03 October 2011
Reasons for updating
- Change to side-effects
Updated on 20 July 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In section 4.4, latex warning has been added
- In section 4.9, No case of overdose reported has been changed to there have been reports of administration of higher than recommended dose"
- In section 6.6, inserted the following text “The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered. Before use, the syringe should be well shaken”
- In section 10, the date of the text has been revised from December 2007 to 03/2011
Updated on 06 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 04 February 2010
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 01 December 2008
Reasons for updating
- Introduction of new pack/pack size
- Change to date of revision
Updated on 28 November 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 February 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2007
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 06 September 2006
Reasons for updating
- Change to packaging
Updated on 22 August 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Section 1 - update to name
· Section 2 - words updated for clarification
· Section 3 - updated to include description of pharmaceutical form
· Section 4.2 Primary vaccination - the need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used.
· Section 4.2 Immunocompromised vaccinees, Revaccination of non-responders and Special dosage recommendation for known of presumed exposure to hepatitis B virus - the recommendations for serologic testing, and administration of additional doses if needed have been strengthened.
· Section 4.2 Method of administration - updated to ensure vaccine not injected intravascularly and reference to see section 6.6 for instructions for preparation.
· Section 4.5 – inclusion of a sentence regarding concomitant administration
· Section 4.7 – wording change for clarification.
· Section 5.1 – additional information provided on clinical trials and booster doses.
· Section 6.2 – wording change for clarification
· Section 6.6 – inclusion of additional sentence
with regards to disposal of waste.
· Section 10 – update to date of revision of the text
Updated on 19 June 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 20 June 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)